- Patients who are pregnant are not eligible. There is not enough medical information to know what the risks might be to a breast-fed infant or to an unborn child carried by a mother who is taking part in the study. If patient is of childbearing age, sexual partner and the patient must use proven birth control measures while on the study. Effective methods of contraception are oral contraceptives, diaphragm, condom, contraceptive foam or male/female sterilization. If the patient is breast-feeding, they must stop breast-feeding. If the patient is still having period and can become pregnant, a pregnancy test must be done before taking part in the study. The pregnancy test must be taken 7 days prior to taking part in the study. If the pregnancy test is positive, the patient will not be able to take part in the study.